Diabetic Peripheral Neuropathy Clinical Trial
Official title:
Effect of Antigravity Treadmill Training on the Gait Performance and Functional Balance in Patients With Diabetic Peripheral Neuropathy. Randomized Controlled Trial
Verified date | September 2022 |
Source | Umm Al-Qura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Diabetic Peripheral Neuropathy and associated complications became globally serious arousing health problems. Aim: To evaluate the effect of Antigravity treadmill training on gait performance and functional balance in patients with Diabetic Peripheral Neuropathy. Design: Single-blinded randomized controlled trial. Setting: Outpatient rehabilitation unit. Population: Sixty-eight eligible participants with Diabetic Peripheral Neuropathy were randomly allocated to Five groups: group-A (100% weight-bearing; n=14), group-B (70% weight-bearing; n=13), group-C (50% weight-bearing; n=14), group-D (30% weight-bearing; n=13), group-E (control group; n=14). Methods: Participants in study groups A, B, C, and D received moderate intensity (50-70% heart rate reserve) aerobic exercise training program on the antigravity treadmill (AlterG, Inc., Fremont, CA, USA) 3 times/week for 12-weeks. The gait performance (using the dynamic gait index) and the functional balance (using the Berg balance scale) variables were evaluated at 3-time points: baseline (evaluation-1), after 12 training weeks (evaluation-2), and 3 months post-training cessation (evaluation-3).
Status | Completed |
Enrollment | 68 |
Est. completion date | June 8, 2022 |
Est. primary completion date | June 8, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility | Inclusion Criteria: - Elderly with diabetic polyneuropathy. - Diagnosed as having uncontrolled Type 2 Diabetes Mellitus, with glycosylated hemoglobin (HbA1c) levels between 7 and 11 and fasting glucose levels ranging from 7.0 -11.1 mmol/L. - Treated only with oral anti-diabetic agents (not taking insulin), Pharmacological treatment had to be stable for at least 3 months before the study. - Able to walk independently with or without an assistive device. - Scored 19 points or less in the "dynamic gait index. Exclusion Criteria: - Type 1 Diabetes Mellitus, - Patient with malnutrition (Body mass index < 21 kg/m2 or with recent weight loss > 5% body weight in the last month or > 10% in six months). - Patients With any severe chronic or uncontrolled comorbid condition such as recent myocardial infarction, unstable angina, acute congestive heart failure, third-degree heart block, and uncontrolled arrhythmia. - Patients will be excluded also if they have abnormal skin integrity e.g. wounds or scar tissues or are on other complementary treatments. - History of serious cerebrovascular or cardiovascular diseases, and severe debilitating musculoskeletal problems). |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Umm Al-Qura University | Jedda |
Lead Sponsor | Collaborator |
---|---|
Umm Al-Qura University |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The gait performance | The gait performance (evaluated using the dynamic gait index). The dynamic gait index is composed of eight items/ tasks. According to the participant's performance; each item is scored on a 4-points ordinal scale from 0 to 3; with "0" indicating the worst achievement (severe impairment) while "3" represents the best score (normal performance). | 12-weeks | |
Primary | The functional balance | The functional balance (evaluated using the Berg balance scale). the Berg balance scale constitutes 14 functional tasks, with each task score ranging from "0 to 4" where "0" indicates the lowest level of function; while "4" indicates the independent performance of the task. | 12-weeks | |
Secondary | Fasting blood glucose level | Fasting blood glucose level | 12-weeks |
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